Contemporary clinical trials communications · 2021
Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Cassarly Christy, Doyle Anna, Ly Trinh, Horn Janet, Aitchison Mary, Elm Jordan, Fridriksson Julius, Bonilha Leonardo
Аннотация
BACKGROUND: and purpose: Speech entrainment therapy (SET) is a computerized therapeutic approach that involves mimicking an audiovisual speech model to improve speech production. In a pilot study using SET for treatment of post-stroke non-fluent aphasia, significant gains were achieved in verbs per minute (VPM) during discourse using untrained items 1 and 6 weeks after treatment, suggesting that SET may yield meaningful improvements in fluent spontaneous speech for individuals with non-fluent aphasia.
METHODS: The Speech Entrainment for Aphasia Recovery (SpARc) trial is a prospective, randomized, assessor-blinded, multicenter phase II clinical trial studying persons with chronic post-stroke non-fluent aphasia. Participants will be randomized to 3 weeks, 4.5 weeks, or 6 weeks of SET delivered via telehealth or a no SET control condition for 6 weeks. 80 adults (ages 21-81) with history of left hemisphere ischemic or hemorrhagic stroke with residual chronic (>6 months post stroke) non-fluent aphasia diagnosed by the Western Aphasia Battery-Revised (WAB-R) will be randomized (1:1:1:1) over 4 years. The trial will be conducted at the clinical research facilities at three sites: the Medical University of South Carolina, the University of South Carolina, and the University of Utah.
CONCLUSIONS: This paper details the trial design of the SpARc trial, which aims to determine the dose of SET that will generate the highest effect size on speech fluency, VPM, sustained at 3 months post-treatment compared to a no SET control arm, for individuals with chronic post-stroke non-fluent aphasia to permit a future definitive trial to test the clinical utility of SET.
METHODS: The Speech Entrainment for Aphasia Recovery (SpARc) trial is a prospective, randomized, assessor-blinded, multicenter phase II clinical trial studying persons with chronic post-stroke non-fluent aphasia. Participants will be randomized to 3 weeks, 4.5 weeks, or 6 weeks of SET delivered via telehealth or a no SET control condition for 6 weeks. 80 adults (ages 21-81) with history of left hemisphere ischemic or hemorrhagic stroke with residual chronic (>6 months post stroke) non-fluent aphasia diagnosed by the Western Aphasia Battery-Revised (WAB-R) will be randomized (1:1:1:1) over 4 years. The trial will be conducted at the clinical research facilities at three sites: the Medical University of South Carolina, the University of South Carolina, and the University of Utah.
CONCLUSIONS: This paper details the trial design of the SpARc trial, which aims to determine the dose of SET that will generate the highest effect size on speech fluency, VPM, sustained at 3 months post-treatment compared to a no SET control arm, for individuals with chronic post-stroke non-fluent aphasia to permit a future definitive trial to test the clinical utility of SET.